Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia

Malaria Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02793414
• Other study ID #: VOCE
• Status: Withdrawn
• Start date: September 2016
• Est. completion date: January 2018

Study information

• Verified date: October 2020
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath indicative of an acute malaria infection. The investigators plan to enroll 75 malaria patients and 175 febrile non-malaria patients in Ethiopia.

Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a breath sample to assess the presence of biomarkers at a reference center. Malaria patients identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD testing will be performed concurrently to identify prevalent G6PD variants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Malaria cohort

• Age =5 years of age

• Malaria microscopy and / or Malaria RDT confirmed malaria infection

• Fever (axillary temperature =37.5°C) or history of fever in preceding 48 hours

• Written informed consent Febrile controls

• Age =5 years of age

• Fever (axillary temperature =37.5°C) or history of fever in preceding 48 hours

• Absence of a malaria episode confirmed by malaria microscopy

• Written informed consent

Related Conditions & MeSH terms

• Malaria

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menzies School of Health Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of the VOC breathalyser	Sensitivity and specificity of the VOC breathalyser compared to microscopy, rapid diagnostic tests (RDTs) and PCR for the diagnosis of clinical malaria.	7 days
Secondary	Correlation of malaria parasite density with VOC concentrations	The correlation of malaria parasite density with VOC concentrations in patients with clinical and subpatent malaria and the recovery profile of VOC following acute malaria.	7 days
Secondary	G6PD variants	G6PD variants within the local population	1 day
Secondary	G6PD activity in U/gHb	The distribution of G6PD enzyme activity in the local population measured in U/gHb.	1 day
Secondary	Performance characteristics of qualitative and quantitative G6PD test formats.	Sensitivity and specificity of other G6PD diagnostic assays compared to the gold standard spectrophotometry	1 day